NDC 67234-0007-01 — Acne Treatment SALICYLIC ACID 5 mg/g Gel

🆔 Identity & classification

FDA NDC (as labeled) 67234-007-01

Product NDC 67234-007

11-digit billing NDC 67234000701

RxCUI 252296

UNII O414PZ4LPZ

Application # M006

SPL Set ID 31b50718-cc60-460d-aad7-b9620970d411

DEA schedule Non-controlled

Marketing category OTC MONOGRAPH DRUG

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2007-01-02

Route TOPICAL

Dosage form GEL

Substance SALICYLIC ACID

Why two NDCs? The FDA registers this code as 67234-007-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 67234-0007-01. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Salicylic acid and derivatives class.

Drug family (ATC) Salicylic acid and derivatives, Other antifungals for topical use, Antiinflammatory agents, non-steroids

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerNatureplex, LLC

FDA applicationM006 (OTC MONOGRAPH DRUG)

Labeler code67234

First marketedJan 2007

Product typeHuman Otc Drug

Portfolio7 products on file

🔎 All NDCs from Natureplex, LLC

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions that involve scaling or overgrowth of skin cells such as psoriasis (a skin disease in which red, scaly patches form on some areas of the body), ichthyoses (inborn conditions that cause skin dryness and scaling), dandruff, corns, calluses, and warts on the hands or feet. Topical salicylic acid should not be used to treat genital warts, warts on the face, warts with hair growing from them, warts in the nose or mouth, moles, or b...

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

It's designed to treat acne. Salicylic acid helps by loosening and removing dead skin cells that clog pores — the buildup that leads to breakouts. The multi-step system on this lab...
What is this salicylic acid product actually supposed to do for my skin?
Some mild tingling, stinging, and peeling is actually expected — that's the salicylic acid doing its job by clearing away dead skin cells. But if the burning or peeling feels exces...
My skin feels like it's burning and peeling. Is that normal?

📖 Read our full Salicylic Acid Topical guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII BYR0546TOW
DMDM hydantoin is a preservative chemical used to prevent the growth of bacteria and fungi in medicines. It helps keep the product safe and stable throughout its shelf life.
UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
UNII L605B5892V
A plant-derived thickener made from cellulose. It increases the medicine's thickness and helps it spread evenly, commonly used in gels, creams, and eye drops to improve texture and how the product coats or clings to surfaces.
UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

7 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statescitric acid, sodium phosphate dibasic, DMDM hydantoin, glycerin, hydroxyethylcellulose, isopropyl alcohol, methylparaben, polysorbate-20, propylene glycol, propylparaben, purified water

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per g	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Proactiv Blackhead Dissolving .5 g/100mL 11410-0024-05	Alchemee,	1 tube	—	—	FDA listed	—
Shiseido Waso Koshirice Acne Calming Treatment .1 g/20mL 58411-0615-60	SHISEIDO	1 tube	—	—	FDA listed	—
All Acne Treatment .5 g/100g 63347-0130-01	Blaine	1 bottle	—	—	FDA listed	—
Acne Treatment 5 mg/gthis 67234-0007-01	Natureplex,	1 tube	—	—	FDA listed	—
Clear Smart Clear Pore Hydrator .5 g/100mL 68828-0701-01	Distribuidora	50 ml	—	—	FDA listed	—
Neutrogena Evenly Clear Acne Gel Moisturizer 5 mg/g 69968-0946-01	Kenvue	12 tubes	—	—	FDA listed	—
Scrub So Clean Acne-Fighting Super Scrub .5 g/100mL 70626-0107-11	ASPIRE	100 ml	—	—	FDA listed	—
CAUDALIE Vinopure Acne Serum .15 g/30mL 76296-0070-10	Caudalie	1 bottle	—	—	FDA listed	—
Drs. ACNE CLEAR 5 mg/g 80489-0300-01	OL	1 tube	—	—	FDA listed	—
Gentle Acne Serum .5 g/100mL 83286-0016-01	Drmtlgy,	59 ml	—	—	FDA listed	—
Azelaq 5 mg/mL 87110-0003-01	METHODIQ	1 bottle	—	—	FDA listed	—
Derm Acne Solution Gel .5 g/100g 87512-0003-01	Yantai	10 g	—	—	FDA listed	—
SOS Rituals Glow Away Blemish Spot Treatment 5 mg/g 85179-0007-00	I	14.5 g	—	—	FDA listed	—
Neutrogena deep clean purifying cooling gel scrub 5 mg/g 69968-0740-04	Kenvue	119 g	—	—	FDA listed	—
Neutrogena Skin Clearing Blemish Concealer - Light 10 5 mg/g 69968-0805-01	Kenvue	1 applicator	—	—	FDA listed	—
Neutrogena Skin Clearing Blemish Concealer - Medium 15 5 mg/g 69968-0812-01	Kenvue	1 applicator	—	—	FDA listed	—
b pure Blemish Concealer for Acne Prone Skin Nude 5 mg/g 80684-0108-00	Fourstar	1.4 g	—	—	FDA listed	—
b pure Blemish Concealer for Acne Prone Skin Fair 5 mg/g 80684-0109-00	Fourstar	1.4 g	—	—	FDA listed	—
Neutrogena Skin Clearing Blemish Concealer - Fair 05 5 mg/g 69968-0810-01	Kenvue	1 applicator	—	—	FDA listed	—
Neutrogena Skin Clearing Blemish Concealer - Buff 09 5 mg/g 69968-0811-01	Kenvue	1 applicator	—	—	FDA listed	—

About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2007

On the market since

Jan 2007

📍

2026

Currently FDA-listed

19 years listed

🔒

·

No generic listed yet

brand only

ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Salicylic Acid (matched by generic name) — the program that covers self-administered drugs. 2 manufacturers.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Salicylic Acid. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$11.2K

Claims incl. refills

43

Beneficiaries

35

Spend / beneficiary

$319.01

Spend / claim

$259.66

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Acne Treatment (this brand).

Top reported reactions

Pruritus273

Rash247

Vomiting245

Pain236

Nausea227

Headache223

Condition Aggravated214

Reporter sex

Male · 38%

Female · 61%

Unknown · 1%

Serious outcomes

Death658

Life-threatening227

Disabling169

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
67234-0007-01 You're viewing this	1 TUBE in 1 BOX (67234-007-01) / 42 g in 1 TUBE	2007-01-02	Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?

An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 67234-007-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 67234-0007-01, written without dashes as 67234000701. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 67234-0007-01, the first segment (67234) is the labeler code FDA assigned to Natureplex, LLC; the middle segment (0007) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Natureplex, LLC. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Natureplex, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose

🎯 Indications and Usage 6 words ▾

Use For the treatment of acne.

⏱️ Dosage and Administration 97 words ▾

Directions Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below clean the skin thoroughly before applying this product cover entire affected area with a thin layer 1 to 3 times daily because excessive drying of skin may occur, start with one application daily, and gradually increase to 2 or 3 times daily if needed or as directed by a doctor if bothersome dryness or peeling occurs, reduce application to once a day or every other day

⚠️ Warnings 71 words ▾

Warnings For external use only. When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

📦 Storage and Handling 28 words ▾

Other information store at 15 to 30°C (59 to 86°F) close cap tightly after use Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

🧪 Active Ingredient 5 words ▾

Active ingredient Salicylic Acid 0.5%

🧪 Inactive Ingredients 20 words ▾

Inactive ingredients citric acid, sodium phosphate dibasic, DMDM hydantoin, glycerin, hydroxyethylcellulose, isopropyl alcohol, methylparaben, polysorbate-20, propylene glycol, propylparaben, purified water

🎯 Purpose 3 words ▾

Purpose Acne Treatment

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

🔗 Related NDC lookups

🧪 All Salicylic Acid NDCsSame ingredient 🏭 All Natureplex, labeler NDCsLabeler code 67234 📖 Read the Salicylic Acid drug informationUses, warnings & side effects